First Wave BioPharma’s (NASDAQ:FWBI) is unlikely to achieve the primary endpoint based on preliminary results from the Phase 2 SPAN study for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis (CF).
First Wave is continuing to assess the data and expects to report additional findings on primary and secondary endpoints in approximately eight weeks.
However, initial data from the study indicated the company’s enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase.
The Phase 2 SPAN clinical trial was designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving 13 patients.
The primary efficacy endpoint is the coefficient of fat absorption, with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption.
Based on the initial safety and efficacy results, First Wave plans to pursue an end-of-Phase 2 meeting with the FDA to review the data and discuss the parameters for a registrational Phase 3 clinical trial that would satisfy the requirements for a biologics license application.
First Wave BioPharma anticipates conducting the end-of-Phase 2 meeting in the fourth quarter of 2023.
